Limited Competition: Continued Development of INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndromE) Project Data Coordinating Center (U2C Clinical Trial Not Allowed)

The National Institutes of Health (NIH) has announced a limited competition Notice of Funding Opportunity (NOFO) for continued support of the INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndrome) Project Data Coordinating Center (DCC). This initiative, reissuing RFA-OD-20-007, is supported by the NIH’s Office of the Director, along with the National Heart, Lung, and Blood Institute (NHLBI) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The primary objective of this NOFO is to maintain and enhance the DCC, a critical component of the INCLUDE Project, which facilitates data integration, sharing, and research collaboration aimed at improving health outcomes for individuals with Down syndrome. The INCLUDE Project addresses co-occurring health conditions common to individuals with Down syndrome, examining a broad array of conditions such as cognitive decline, congenital heart defects, and immune disorders, while also exploring the unique resistance to certain conditions like atherosclerosis and solid tumors. This NOFO focuses on Component 2 of the INCLUDE Project, which supports the development of a large cohort for Down syndrome research, enabling deep phenotyping, comprehensive data collection, and clinical trial readiness. The DCC’s primary functions include maintaining the INCLUDE Data Hub, a secure data repository, managing a data portal for resource sharing, and offering cloud-based data analysis tools. The goal is to centralize data resources and tools to support a global knowledge base on Down syndrome, addressing the variability in health and developmental challenges faced by individuals with the condition. The award will be structured as a cooperative agreement with a total annual funding of up to $6 million, and the project period may extend up to five years. Only current recipients of the previous RFA-OD-20-007 are eligible to apply. Applications must be submitted through Grants.gov by December 12, 2024, with the project anticipated to begin in July 2025. The DCC will consist of three cores: the Data Hub Core, which oversees the data repository; the Data Management Core, which handles data collection, harmonization, and quality control; and the Administrative and Outreach Core, responsible for program management, outreach, and user engagement. Applicants must demonstrate capabilities in handling complex, multi-component data systems, as well as expertise in Down syndrome research. Evaluation criteria for this NOFO include scientific and technical merit, relevance to NIH’s mission, and cost realism. Applications will be peer-reviewed by the Center for Scientific Review and assessed by the NIH Advisory Council. Key considerations include the significance of the DCC in addressing health challenges related to Down syndrome, the expertise of the project team, the innovativeness of the approach, and the feasibility of the proposed methodology. Additional criteria specific to the core functions, such as data integration and community outreach, will also be evaluated. The NIH also requires adherence to specific data-sharing and genomic data management policies, as well as compliance with the FAIR principles to ensure data resources are findable, accessible, interoperable, and reusable. Awardees are expected to maintain close collaboration with NIH program staff and the INCLUDE Steering Committee. This partnership will involve setting milestones, promoting standardized data collection, and enabling cross-platform interoperability. An emphasis will be placed on creating resources that can integrate data from diverse sources, including clinical trials, electronic health records, and multi-omics studies, to foster a cohesive Down syndrome research environment.